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StrokePhase 4NCT02768571

Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

A Phase 4 study testing Cerebrolysin in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study, E-COMPASSII is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 80 subacute stroke patients with severe motor involvement. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Stroke
What is being tested?
Cerebrolysin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteSouth Korea
Study dates
14 Mar 2016to 14 Feb 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The first-ever stroke (ischemic)
  • Confirmed by CT or MRI
  • Subacute stage: less than 1 week
  • Severe motor function involvement (FMA < 50)
  • Age: between 19 and 80 years
  • Inpatients
  • Written informed consent obtained from the patient or legally authorized representative

Who cannot join

  • Contraindication of MRI
  • Progressive or unstable stroke
  • Pre-existing and active major neurological disease
  • Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
  • A history of significant alcohol or drug abuse in the prior 3 years
  • Advanced liver, kidney, cardiac, or pulmonary disease
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  • A terminal medical diagnosis consistent with survival < 1 year
  • Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale
  • Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
  • Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin
  • Current enrolment in another therapeutic study of stroke or stroke recovery
  • Total serum bilirubin > 4 mg/dL, alkaline phosphatase > 250 U/L, SGOT/AST > 150 U/L, SGPT/ALT > 150 U/L, or creatinine > 3.5 mg/dL; or cardiopulmonary deficits large enough to interfere with reasonable participation in physiotherapy during the trial.
  • Previous porcine brain peptide administration history

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Patients With Severe Motor Involvement at Subacute Phase of Stroke

This study, E-COMPASSII is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 80 subacute stroke patients with severe motor involvement. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke. Secondary objectives are to evaluate the safety profile of cerebrolysin and to test the hypothesis that subacute stroke patients with severe motor involvement randomized to administration of Cerebrolysin combined with rehabilitation for 3 weeks show better outcome on global function (Korean version Modified Barthel Index, K-MBI), severity of stroke (National Institute of Health Stroke Scale, NIHSS), cognitive function (Korean Version of Mini-Mental State Exam, K-MMSE; Korean version Montreal Cognitive Assessment, K-MoCA), upper limb function (Action Research Arm Test, ARAT; Box and block test, B\&B) and neuroplasticity measure (resting-state functional MRI(rsfMRI), diffusion tensor image(DTI), and motor evoked potential(MEP)) at 3 months after stroke.

Read the detailed description

Randomized double-blinded, placebo-controlled multicenter study with two treatment groups

Number of Patients: 80 patients (n = 40 per group) 5 study centers will participate in this study.

Group 1(Cerebrolysin): cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation

Group 2(Placebo): saline 100 ml/day * 21 days with rehabilitation

Conditions
Stroke
Being tested
Cerebrolysin, Placebo
Keywords
cerebrolysin, stroke, motor function
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CerebrolysinDrug

    Also called Porcine brain peptide

    Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation

  • PlaceboDrug

    Also called Saline

    Placebo- saline 100 ml/day * 21 days with rehabilitation

Study groups in NCT02768571
Study groupRoleWhat they receive
CerebrolysinExperimentalCerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation * Study drug schedule - given from day 8 after stroke, but, if day 8 is weekend, the given day is the next Monday(day 9~10) * Rehabilitation * 3 hours (physiotherapy: 2 hours, occupational therapy: 1 hour) / day * 5 times/week for 3 weeks Duration of Treatment: Study drug will be given once daily by intravenous infusion for 21 consecutive days on study day 8 ~ 28. The clinical observation period for each patient will be 90 days and will include four clinical evaluation visits at Screening(day ≤ 7), Baseline(day 8) and on study day 29, and 90.
Receives: Drug: Cerebrolysin
PlaceboPlacebo comparatorSaline 100 ml/day * 21 days with rehabilitation * Study drug schedule - given from day 8 after stroke, but, if day 8 is weekend, the given day is the next Monday(day 9~10) * Rehabilitation * 3 hours (physiotherapy: 2 hours, occupational therapy: 1 hour) / day * 5 times/week for 3 weeks Duration of Treatment: Study drug will be given once daily by intravenous infusion for 21 consecutive days on study day 8 ~ 28. The clinical observation period for each patient will be 90 days and will include four clinical evaluation visits at Screening(day ≤ 7), Baseline(day 8) and on study day 29, and 90.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score of Fugl-Meyer assessment (FMA)

    Motor function

    Measured: 3 months after stroke

Secondary outcomes (7)

  1. Score of Korean version Modified Barthel Index (K-MBI)

    Global function

    Measured: 3 months after stroke

  2. Score of National Institute of Health Stroke Scale (NIHSS)

    Severity of stroke

    Measured: 3 months after stroke

  3. Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA)

    Cognitive function

    Measured: 3 months after stroke

  4. Score of Action Research Arm Test (ARAT) and box and block test

    Upper limb function

    Measured: 3 months after stroke

  5. Score of EuroQol (EQ-5D)

    Quality of life

    Measured: 3 months after stroke

  6. Days of Length of hospital stay

    Measured: 3 months after stroke

  7. Brain activation of resting-state functional MRI

    Neuroplasticity measure

    Measured: 3 months after stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2016 (estimated)
  2. Study start14 Mar 2016
  3. Primary completion14 Feb 2019
  4. Study completion14 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02768571
Sponsor's protocol ID
2015-10-034
Status last verified
Sep 2019
First submitted
4 Mar 2016
Last updated
20 Sep 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cerebrolysin in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of Fugl-Meyer assessment (FMA) (time frame: 3 months after stroke). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02768571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.

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